Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT04287660
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients
- Detailed Description
This is a phase 3, single arm, multi-center study. The patients will receive BiRd regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous BCMA-directed CAR T-cells in newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
- Age 18-75
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- BCMA positive as detected with flowcytometry or ELISA.
- Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL
- Patients are pregnant or lactating.
- Nonsecretory MM.
- History of previous treatment of MM.
- Patients with uncontrolled active infection.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with HIV infection.
- Patients with atrial or venous thrombosis or embolism.
- Patients with myo-infarction or severe arrythmia in the recent 6 months.
- Other comorbidities that investigators considered not suitable for this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BiRd combined with BCMA CAR T-cells infusion clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells -
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) 4 weeks after CAR T-cells infusion (up to 14 weeks) ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, respectively, after counting ≥100 plasma cells). Complete Response (CR)：negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Very good partial response (VGPR)：serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. Partial response (PR): ≥50% reduction of serum M-protein plus reduction in 24 h urine M-protein by ≥90% or to \<200 mg per 24 h.
- Secondary Outcome Measures
Name Time Method Event-free survival (EFS) 4 years time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause
Overall survival (OS) 4 years time from enrollment to the date of death from any cause
Cumulative incidence of relapse(CIR) 4 years time from the date of achievement of a remission until the date of relapse
Number of adverse events 2 years adverse events are evaluated with CTCAE V5.0
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China